In order for a drug to receive approval from the Food and Drug Administration it must go through clinical trials. This means testing on human subjects to prove that the drug is both safe and effective. People tend to make a lot of assumptions about FDA approval, and many people feel that as long as a drug is FDA approved it is safe and that’s all they need to know, but FDA approval can be misleading.
Clinical trials are paid for by the pharmaceutical companies, so there is a bias from the very beginning. The FDA only requires results of clinical trials which pertain to the specific purpose for which approval is being sought. Results of any other testing of a medication, including negative results, do not have to be reported to the FDA. The FDA does not disclose any results to the public, whether negative or positive, without the pharmaceutical company’s permission. It is not unusual for the FDA to be aware of negative results and potential hazards of a drug, and withhold the information from the public.
If you have been injured by a defective drug – regardless of whether or not it was approved by the FDA, please contact one of the following pharmaceutical injury lawyers:
